The following data is part of a premarket notification filed by Computer Motion, Inc. with the FDA for Bipolar Grasper And Bipolar Scissors For The Zeus Microwrist Surgical System.
Device ID | K030578 |
510k Number | K030578 |
Device Name: | BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM |
Classification | System, Surgical, Computer Controlled Instrument |
Applicant | COMPUTER MOTION, INC. 130-B CREMONA DR. Goleta, CA 93117 |
Contact | Cathy Stupak |
Correspondent | Cathy Stupak COMPUTER MOTION, INC. 130-B CREMONA DR. Goleta, CA 93117 |
Product Code | NAY |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-24 |
Decision Date | 2003-06-24 |
Summary: | summary |